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Efficacy and Safety of Angiotensin II Receptor Blockade in Elderly Patients With Diabetes

¹ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
² Renal Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
³ Merck Research Laboratories, Merck, West Point, Pennsylvania
⁴ Baker Heart Research Institute, Melbourne, Australia

Address correspondence and reprint requests to Wolfgang C. Winkelmayer, MD, ScD, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA 02120. E-mail: wwinkelmayer{at}partners.org

OBJECTIVE—While national guidelines recommend ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy in patients with diabetes and nephropathy, guidelines concerning elderly patients with diabetes have not endorsed these drugs. We sought to assess the nephroprotective efficacy and safety of ARB therapy in elderly patients by conducting age-specific subgroup analyses using data from the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study.

RESEARCH DESIGN AND METHODS—We studied 1,513 patients with type 2 diabetes and nephropathy who randomly received either losartan or placebo. We tested for effect modification by age of the effect of losartan on the incidence of the predefined end points (doubling of serum creatinine, end-stage renal disease [ESRD], or death) and the risk of adverse events.

RESULTS—Of 1,513 participants, 421 (27.8%) were aged >65 years (maximum age 74 years). Age did not modify the efficacy of losartan in reducing the risk of the primary outcome, a composite of doubling of serum creatinine, ESRD, or death (P_interaction = 0.66) or its individual components (all P_interaction > 0.44). In patients aged >65 years, losartan reduced the risk of ESRD by 50% (95% CI 30–81, P = 0.005). We found no evidence that older patients were more likely to experience adverse events from losartan such as a rise in serum creatinine or hyperkalemia than younger patients.

CONCLUSIONS—Elderly patients had the same level of benefits and risks as younger patients from treatment with losartan. Underuse of ACEI and ARB therapy in elderly patients because of the perceived lack of efficacy or a greater risk of adverse events appears unjustified.

Abbreviations: ACEI, ACE inhibitor • ARB, angiotensin receptor blocker • CKD, chronic kidney disease • ESRD, end-stage renal disease • RAAS, renin-angiotensin-aldosterone system • RENAAL, Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan

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